Adherence to Treatment With Aromatase Inhibitors With or Without Abemaciclib in Patients With Early-stage, Endocrine-dependent, HER2-negative Breast Cancer

What this Trial Is About

Researchers are examining medication adherence in women with early-stage hormone receptor-positive, HER2-negative breast cancer. This study compares adherence rates between patients treated with aromatase inhibitors alone and those receiving aromatase inhibitors combined with the CDK4/6 inhibitor abemaciclib. The study aims to understand how factors like quality of life, cognitive function, attitudes toward therapy, age, and prior treatments influence adherence and treatment discontinuation. Participants include adult women already prescribed aromatase inhibitors with or without abemaciclib as part of their routine care. The study observes these patients over time without altering their prescribed treatments. Two groups are followed: one receiving both aromatase inhibitors and abemaciclib, and the other receiving only aromatase inhibitors. Treatment adherence and discontinuation are tracked during this observational period. Participants will complete quality of life questionnaires (EORTC QLQ-C30 and QLQ-BR23), beliefs about medicines surveys, and cognitive function tests (FACT-Cog) at the start of the study and again at 3 and 6 months after treatment begins. Medication adherence is measured at 3 and 6 months using the Proportion of Days Covered method. Adverse events are monitored throughout the 6-month follow-up. The study is conducted with adult women receiving treatment at the Institute of Oncology Ljubljana, and participation involves providing informed consent and completing scheduled assessments.

Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer